Quality Assurance Jobs at Fortrea | Apply Now For The Role
Are you looking for an exciting opportunity to elevate your career in regulatory affairs and quality assurance jobs? The Regulatory Operations Expert position at Fortrea offers a dynamic role for professionals who want to contribute to global product quality, regulatory compliance, and project oversight across pharmaceutical, chemical, and biological domains. This role provides the perfect platform to work with worldwide teams, support major health authority submissions, and help drive excellence across the product lifecycle.
About Fortrea
Fortrea is a global leader in project management and regulatory affairs services, supporting clients across the pharmaceutical, chemical, and biological industries. With a strong focus on quality, innovation, and operational excellence, Fortrea helps organizations streamline regulatory processes, maintain compliance, and enhance product lifecycle management. The company is known for its global reach, expert teams, and commitment to delivering high-value solutions tailored to client needs.
Job Overview:
Perform various project management and regulatory affairs activities for Fortrea clients. Manage team, including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required. Manage, coordinate, and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents
across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients, either as a support function to the client project groups or as a stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.Summary of Responsibilities:
- The contractor will report to the team lead of the QA Laboratory group of CSQ of the global Product Quality Management (PQM) organization located in Beerse, Belgium.
- The contractor will work from the JnJ premises: Mumbai, Maharashtra, India.
- The team is responsible for quality oversight and quality assurance support for the JnJ laboratories and their contract laboratories used by TDS.
- Review and approval of documents such as, but not limited to, protocols and reports for Method qualification, method validation, transfer, methods, and investigations.
- Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the SMPD laboratories, as well as their contract laboratories.
- Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
- Actively participates in meetings with businesses such as the Capa board, Quality improvement program, and team, e.g., connect meetings.
Qualifications (Minimum Required):
- Bachelor’s or Master’s degree, scientific oriented (pharmaceutical, chemical, or biological sciences) or equivalent by experience.
- 3-5 years’ experience in the pharmaceutical industry.
- Experience and affinity with the laboratory environment (method development, method validation, release & stability testing, micro,…), quality assurance, pharmaceutical development, instrument qualification, IT, automation.
- Ability to work across organizational boundaries, cultures.
- Influencing, negotiation, and partnering in a global environment.
- Positively react to changes and show agile behavior.
- In-depth knowledge of cGMP and ICH guidelines.
- Excellent verbal and written communication skills (English).
- Demonstrates Diversity & Inclusion behavior.
- Team player.
Physical Demands/Work Environment:
- Physical demands: Available for regional or global travel 5-10% of the time, including overnight stays as necessary, consistent with project needs and office location.
- Work environment: Office environment or remote.
